October 2, 2000 - pSMILE



|Occurrence Management Policy |Policy Number |Doc10-14AppH |

| |Effective Date |30-Jul-08 |

|Approval Signature: Laboratory Director |Supersedes |New |

|Last Review |10-Feb-20 |Review by |Heidi Hanes |

|SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or |

|specific protocol requirements. Users are encouraged to ensure compliance with local laws and study protocol policies when considering the |

|application of this document. If you have any questions contact SMILE. |

QSE 8: Occurrence Management - Policy

|Policy |The laboratory identifies, documents, and investigates occurrences (nonconformances); classifies, analyzes, and |

| |trends the information they represent; performs remedial/corrective actions; and identifies the need for root |

| |cause analysis and process improvement. |

|Purpose |This policy provides direction for the processes and procedures to effectively detect and resolve problems and to|

| |classify problems so that corrective actions aimed at removing root causes and improving processes can be planned|

| |and implemented. |

|Responsibility |The Laboratory Supervisor is responsible for problem resolution and investigations. |

| |The Quality Manager and Quality Management Team are responsible for collecting and analyzing occurrence data. |

| |The Lead Technologists are responsible for documentation of complaints and problem resolution. |

|Identifying Occurrences |The laboratory has a means to identify, document, investigate, and respond to complaints from internal/external |

| |customers; recalls of materials, equipment, or software; and other nonconforming events. |

|Investigation and Response to |The laboratory has a procedure for identifying, documenting, and investigating occurrences and performing |

|Occurrences |remedial and corrective actions in response to those nonconforming events. |

|Classifying and Analyzing |The laboratory has a procedure for classifying and analyzing occurrences, including trending information, so that|

|Occurrence Information |the portions of the path of workflow with the most important patient-related and costly problems can be |

| |identified, corrected, and referred for root cause analysis and process improvement. |

|Supporting Documents |The following processes support this policy: |

| |Identifying and Documenting Occurrences |

| |Remedial Actions and Investigation of Occurrences |

| |Analyzing Occurrence Information and Referring for Root Cause Analysis and Process Improvement |

Identifying and Documenting Occurrences - Process

Process for Identifying and Documenting Occurrences

|What Happens |Who’s Responsible |Procedures |

|The laboratory identifies or receives |Laboratory Supervisor |Communication of Safety and Quality Concerns|

|complaints from internal and external |Quality Manager | |

|customers |Technicians/Technologists | |

| |External Customers | |

|The laboratory receives recalls or |Laboratory Supervisor |Inventory Management |

|notification of nonconformances as related to|Laboratory Supply Manager |Communication of Safety and Quality Concerns|

|materials, equipment, or software | | |

|A nonconforming event is identified from |Laboratory Director |Audit-Related SOPs |

|internal/external audits, QC/Calibration/EQA |Laboratory Supervisor |EQA SOPs |

|failures, or management reviews |Quality Manager |Quality Management |

| |Technicians/Technologists |Communication of Safety and Quality Concerns|

|The occurrence is documented on appropriate |Laboratory Supervisor |Communication of Safety and Quality Concerns|

|electronic or paper-based occurrence report |Quality Manager | |

|form |Technicians/Technologists | |

|The form is submitted to the designated |Laboratory Supervisor |Communication of Safety and Quality Concerns|

|individual for further action, including |Quality Manager |Quality Management |

|remedial/corrective actions, root cause |Technicians/Technologists |Process Improvement |

|analysis, and process improvement | |Remedial and Corrective Actions |

Remedial Actions and Investigation of Occurrences - Process

Process for Remedial Actions and Investigation of Occurrences

|What Happens |Who’s Responsible |Procedures |

|Immediate remedial actions are initiated to |Laboratory Supervisor |Communication of Safety and Quality Concerns|

|resolve any immediate concerns related to |Quality Manager |Investigations of Occurrences |

|patient care |Technicians/Technologists |Remedial and Corrective Actions |

|Remedial actions are documented on the |Laboratory Supervisor |Investigations of Occurrences |

|occurrence report form |Quality Manager |Quality Management |

| |Technicians/Technologists |Remedial and Corrective Actions |

|The occurrence is investigated and |Laboratory Supervisor |Investigations of Occurrences |

|documentation is completed |Quality Manager |Quality Management |

| |Quality Management Team | |

|Additional corrective or preventive actions are|Laboratory Supervisor |Investigations of Occurrences |

|completed and documented |Quality Manager |Quality Management |

| |Quality Management Team |Technical SOPs |

| |Technicians/Technologists |Remedial and Corrective Actions |

|Occurrence report form is submitted to |Laboratory Supervisor |Quality Management |

|designated individual for additional occurrence|Quality Manager |Process Improvement |

|analysis |Quality Management Team | |

Analyzing Occurrence Information and Process Improvement Referral - Process

Process for Analyzing Occurrence Information and Process Improvement Referral

|What Happens |Who’s Responsible |Procedures |

|Information regarding individual occurrences is|Quality Manager |Communication of Safety and Quality Concerns |

|entered into an electronic or paper-based |Quality Management Team |Occurrence Report Forms |

|database | |Quality Management |

| | |Occurrence Data Analysis |

| | |Process Improvement |

|Occurrences are categorized, tracked, and |Quality Manager |Occurrence Data Analysis |

|organized in a manner to facilitate analysis of|Quality Management Team |Quality Management |

|collective data | |Process Improvement |

|Database and occurrence report information are |Quality Manager |Occurrence Data Analysis |

|reviewed at regular intervals to identify |Quality Management Team |Quality Management |

|trends in occurrence information | |Process Improvement |

|Management reviews data and allocates resources|Quality Manager |Quality Management |

|for root cause analysis and process improvement|Quality Management Team |Occurrence Data Analysis |

| |Laboratory Management |Process Improvement |

| | |Allocation of Resources |

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